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NCT Number: NCT07286890

Getinge's Beating Heart Product Family Post-Market Clinical Follow-up (PMCF) Study

This observational study aims to collect data on the performance and safety of Getinge's Beating Heart products used during open-heart coronary artery bypass graft surgery. The surgery and the use of the study devices will be done according to the standard of care. Participants will not be required to undergo any study-specific procedures, and information will be collected only until hospital discharge following the surgery.

Recruiting

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Key information

Conditions

Off Pump Coronary Artery Bypass Surgery

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Bosch Gesellschaft für Medizinische Forschung mbH, Stuttgart, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 22 years of age
  • Patient (or a legally authorized representative) is willing and able to provide signed informed consent, if required
  • Undergoing planned beating heart coronary artery bypass graft procedure with/without left atrial appendage closure, where the use of at least one Getinge's Beating Heart study product is anticipated.

Exclusion criteria

  • Patients undergoing heart valve surgery
  • Patients who undergo either planned or unplanned conversion to on pump with arrested heart where Getinge's Beating Heart product(s) have not been used.

Treatment and study plan

Vacuum Stabilizer System

Device

Isolates and provides local immobilization of the target vessel while performing the distal anastomosis on a beating heart.

Vacuum Positioner System

Device

Positions the heart and exposes the coronary artery(ies) when performing the distal anastomosis on a beating heart.

Blower/Mister

Device

Reduces blood in the operative field to improve visibility while performing an anastomosis on a beating heart.

Proximal Seal System

Device

Proximal anastomotic seal technology allows for clampless hemostasis during proximal anastomosis when performing Coronary Artery Bypass Graft (CABG) procedures.

Primary outcomes

  1. Incidence of device-related adverse events

    Time frame: Time period from procedure through study completion, an average of 7 days

    Incidence of device-related adverse events for each subject

  2. Incidence of device-related serious adverse events

    Time frame: Time period from procedure through study completion, an average of 7 days

    Incidence of device-related serious adverse events experienced by subjects

  3. Incidence of technical success

    Time frame: Perioperative/Periprocedural

    Incidence of technical success, based on the number of patients who have documented successful use and performance of the study device(s) when used as intended, out of the study population.

Study contacts

Contact information is provided by the study sponsor or research team.

Sr. Manager, Clinical Affairs

CONTACT

[email protected]

603-921-7318

Sponsors and collaborators

Lead sponsor

Maquet Cardiovascular

Industry

Registry information

Official study title

A Real-World Post-Market Clinical Follow-Up Study to Evaluate the Safety and Performance of Getinge's Beating Heart Product Family in Patients Undergoing Beating Heart Coronary Artery Bypass Graft Surgery

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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